PE20141265A1 - FREEZE-DRIED FORMULATIONS OF FGF-18 - Google Patents
FREEZE-DRIED FORMULATIONS OF FGF-18Info
- Publication number
- PE20141265A1 PE20141265A1 PE2013002832A PE2013002832A PE20141265A1 PE 20141265 A1 PE20141265 A1 PE 20141265A1 PE 2013002832 A PE2013002832 A PE 2013002832A PE 2013002832 A PE2013002832 A PE 2013002832A PE 20141265 A1 PE20141265 A1 PE 20141265A1
- Authority
- PE
- Peru
- Prior art keywords
- concentration
- fgf
- vial
- seq
- freeze
- Prior art date
Links
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/18—Growth factors; Growth regulators
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/18—Growth factors; Growth regulators
- A61K38/1825—Fibroblast growth factor [FGF]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/24—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing atoms other than carbon, hydrogen, oxygen, halogen, nitrogen or sulfur, e.g. cyclomethicone or phospholipids
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
- A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
- A61P19/04—Drugs for skeletal disorders for non-specific disorders of the connective tissue
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
- A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Engineering & Computer Science (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Immunology (AREA)
- Zoology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Gastroenterology & Hepatology (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Organic Chemistry (AREA)
- Physical Education & Sports Medicine (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Molecular Biology (AREA)
- Rheumatology (AREA)
- Biochemistry (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Biophysics (AREA)
- Biomedical Technology (AREA)
- Pain & Pain Management (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Peptides Or Proteins (AREA)
Abstract
REFERIDO A UNA FORMULACION LIOFILIZADA ESTABLE QUE COMPRENDE: A) FACTOR DE CRECIMIENTO DE FIBROBLASTOS 18 (FGF-18), CON UNA CONCENTRACION DE 20 A 300 mcg/VIAL, EL CUAL SE SELECCIONA DE: a) UN POLIPEPTIDO QUE COMPRENDE LOS RESIDUOS DE AMINOACIDO 28-207 DE SEQ ID NO:1, b) UN POLIPETIDO QUE COMPRENDE LOS RESIDUOS DE AMINOACIDOS 28-196 DE SEQ ID NO:1 Y c) UN POLIPEPTIDO QUE COMPRENDE LA SEQ ID NO:2; B) UN TAMPON QUE MANTIENE UN pH ENTRE 6 Y 8, TAL COMO FOSFATO, CON UNA CONCENTRACION DE 5 A 100 mM; C) UN TENSIOACTIVO DE POLOXAMERO, TAL COMO POLOXAMERO 188, CON UNA CONCENTRACION DE 0,1 A 0,4 mg/VIAL; Y D) UN AZUCAR COMO AGENTE ESTABILIZANTE, TAL COMO SACAROSA, CON UNA CONCENTRACION DE 10 A 60 mg/ VIAL. REFERIDO ADEMAS A UN METODO PARA PRODUCIR LA FORMULACION LIOFILIZADA. DICHA FORMULACION ES UTIL PARA EL TRATAMIENTO DE TRASTORNOS DE LOS CARTILAGOS TALES COMO OSTEOARTRITIS O LESION DE LOS CARTILAGOSREFERRED TO A STABLE LYOPHILIZED FORMULATION THAT INCLUDES: A) FIBROBLAST GROWTH FACTOR 18 (FGF-18), WITH A CONCENTRATION OF 20 TO 300 mcg / VIAL, WHICH IS SELECTED FROM: a) A POLYPEPTIDE THAT INCLUDES AMMODIUM RESIDUES 28-207 OF SEQ ID NO: 1, b) A POLYPEPTIDE INCLUDING THE RESIDUES OF AMINO ACIDS 28-196 OF SEQ ID NO: 1 AND c) A POLYPEPTIDE INCLUDING SEQ ID NO: 2; B) A BUFFER THAT MAINTAINS A pH BETWEEN 6 AND 8, SUCH AS PHOSPHATE, WITH A CONCENTRATION OF 5 TO 100 mM; C) A POLOXAMER SURFACTANT, SUCH AS POLOXAMER 188, WITH A CONCENTRATION OF 0.1 TO 0.4 mg / VIAL; AND D) A SUGAR AS A STABILIZING AGENT, SUCH AS SACROSE, WITH A CONCENTRATION OF 10 TO 60 mg / VIAL. ALSO REFERRED TO A METHOD TO PRODUCE THE LYOPHILIZED FORMULATION. SUCH FORMULATION IS USEFUL FOR THE TREATMENT OF DISORDERS OF THE CARTILAGES SUCH AS OSTEOARTHRITIS OR INJURY OF THE CARTILAGES
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP11170437 | 2011-06-17 | ||
| US201161499216P | 2011-06-21 | 2011-06-21 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| PE20141265A1 true PE20141265A1 (en) | 2014-09-29 |
Family
ID=47356563
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PE2013002832A PE20141265A1 (en) | 2011-06-17 | 2012-06-15 | FREEZE-DRIED FORMULATIONS OF FGF-18 |
Country Status (31)
| Country | Link |
|---|---|
| US (2) | US9326944B2 (en) |
| EP (2) | EP3056211A1 (en) |
| JP (1) | JP5981538B2 (en) |
| KR (1) | KR102019520B1 (en) |
| CN (2) | CN103619347A (en) |
| AR (1) | AR086956A1 (en) |
| AU (1) | AU2012268987B2 (en) |
| BR (1) | BR112013032400B1 (en) |
| CA (1) | CA2836667C (en) |
| CL (1) | CL2013003618A1 (en) |
| CO (1) | CO6940377A2 (en) |
| CY (1) | CY1117933T1 (en) |
| DK (1) | DK2720710T3 (en) |
| EA (1) | EA024937B1 (en) |
| EC (1) | ECSP14013157A (en) |
| ES (1) | ES2575732T3 (en) |
| HR (1) | HRP20160566T1 (en) |
| HU (1) | HUE028355T2 (en) |
| IL (1) | IL229977A (en) |
| MX (1) | MX338017B (en) |
| MY (1) | MY170630A (en) |
| PE (1) | PE20141265A1 (en) |
| PL (1) | PL2720710T3 (en) |
| PT (1) | PT2720710E (en) |
| RS (1) | RS54875B1 (en) |
| SG (1) | SG195021A1 (en) |
| SI (1) | SI2720710T1 (en) |
| TW (1) | TWI527590B (en) |
| UA (1) | UA113174C2 (en) |
| WO (1) | WO2012172072A1 (en) |
| ZA (1) | ZA201308698B (en) |
Families Citing this family (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| TWI527590B (en) * | 2011-06-17 | 2016-04-01 | 艾瑞斯貿易公司 | Freeze-dried formulations of fgf-18 |
| SG11201604972TA (en) * | 2013-12-24 | 2016-07-28 | Ares Trading Sa | Fgf-18 formulation in alginate/collagen hydrogels |
| US20180236032A1 (en) * | 2015-08-13 | 2018-08-23 | Merck Patent Gmbh | Combination composition comprising fgf-18 compound |
| WO2019092637A1 (en) * | 2017-11-10 | 2019-05-16 | Novartis Ag | Extended release formulations for intra-articular applications |
| CN109836487B (en) * | 2019-03-01 | 2022-06-17 | 重庆派金生物科技有限公司 | Human fibroblast growth factor 18, and soluble recombinant expression method, preparation and application thereof |
| CN112121150A (en) * | 2019-06-24 | 2020-12-25 | 杭州生物医药创新研究中心 | Fibroblast growth factor 10 freeze-dried powder |
| CN113304063A (en) * | 2021-04-23 | 2021-08-27 | 四川省恩乐生物工程有限公司 | Composition for skin beautifying and anti-aging and preparation method thereof |
Family Cites Families (26)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5217954A (en) * | 1990-04-04 | 1993-06-08 | Scios Nova Inc. | Formulations for stabilizing fibroblast growth factor |
| GB9015824D0 (en) | 1990-07-18 | 1990-09-05 | Erba Carlo Spa | Stable pharmaceutical compositions containing a fibroblast growth factor |
| CN1151842C (en) * | 1995-07-27 | 2004-06-02 | 基因技术股份有限公司 | Stable isotonic lyophilized protein formulation |
| US20010056066A1 (en) * | 1996-07-26 | 2001-12-27 | Smithkline Beecham Corporation | Method of treating immune cell mediated systemic diseases |
| PT931148E (en) | 1996-10-16 | 2006-06-30 | Zymogenetics Inc | HOMOLOGES OF THE FIBROBLASTIC GROWTH FACTOR |
| CN1184673A (en) * | 1996-12-13 | 1998-06-17 | 中国医科大学 | FGF raw extraction polypeptide growth factor mixture, and extraction process therefor |
| US6451303B1 (en) | 1998-10-13 | 2002-09-17 | Chiron Corporation | Method of treating coronary artery disease by administering a recombinant FGF |
| AU1804201A (en) | 1999-12-02 | 2001-06-12 | Zymogenetics Inc. | Methods for targeting cells that express fibroblast growth receptor-3 or-2 |
| CN1303714A (en) * | 2000-01-13 | 2001-07-18 | 重庆多泰制药有限公司 | II type collagen oral gastric solubility preparation |
| US7754686B2 (en) * | 2000-08-31 | 2010-07-13 | Novartis Vaccines And Diagnostics, Inc. | Stabilized FGF formulations containing reducing agents |
| JP4317010B2 (en) * | 2001-07-25 | 2009-08-19 | ピーディーエル バイオファーマ，インコーポレイティド | Stable lyophilized pharmaceutical formulation of IgG antibody |
| DE10204792A1 (en) * | 2002-02-06 | 2003-08-14 | Merck Patent Gmbh | Lyophilized preparation containing immunocytokines |
| AU2003279835B2 (en) * | 2002-10-07 | 2009-09-10 | Zymogenetics, Inc. | Methods of administering FGF18 |
| CA2517310C (en) * | 2003-02-28 | 2015-11-24 | Chugai Seiyaku Kabushiki Kaisha | Stabilized protein-containing formulations comprising a poloxamer |
| BRPI0510527A (en) * | 2004-06-01 | 2007-10-30 | Ares Trading Sa | protein stabilization method |
| JP5948627B2 (en) * | 2004-10-29 | 2016-07-20 | レイショファーム ゲーエムベーハー | Fibroblast growth factor (FGF) remodeling and carbohydrate pegylation |
| PT1828239E (en) | 2004-12-10 | 2011-10-27 | Zymogenetics Inc | Fgf18 production in prokaryotic hosts |
| KR101378194B1 (en) * | 2005-12-20 | 2014-03-27 | 브리스톨-마이어스 스큅 컴퍼니 | Stable protein formulations |
| JP4729740B2 (en) * | 2006-01-11 | 2011-07-20 | 独立行政法人産業技術総合研究所 | Mutant growth factor with altered receptor specificity and pharmaceutical composition containing the same |
| EP1986612B1 (en) | 2006-02-07 | 2012-09-12 | Shire Human Genetic Therapies, Inc. | Stabilized composition of glucocerebrosidase |
| JP5815206B2 (en) | 2006-08-25 | 2015-11-17 | アレス トレーディング ソシエテ アノニム | Treatment of cartilage disorders using FGF-18 |
| CN101663046B (en) * | 2007-03-30 | 2017-07-28 | Ambrx公司 | Through modifying the polypeptides of FGF 21 and its purposes |
| BRPI0809583B1 (en) | 2007-03-30 | 2022-02-22 | Ambrx, Inc | Modified fgf-21 polypeptide, composition comprising the same, method for producing said fgf-21 polypeptide, and cell comprising a polynucleotide |
| CN101181280B (en) * | 2007-11-23 | 2010-07-14 | 深圳万乐药业有限公司 | Pirarubicin freeze-dry preparations and preparation method thereof |
| AU2008340429C1 (en) * | 2007-12-21 | 2016-09-08 | F. Hoffmann-La Roche Ag | Antibody formulation |
| TWI527590B (en) * | 2011-06-17 | 2016-04-01 | 艾瑞斯貿易公司 | Freeze-dried formulations of fgf-18 |
-
2012
- 2012-06-11 TW TW101120864A patent/TWI527590B/en active
- 2012-06-15 BR BR112013032400-7A patent/BR112013032400B1/en active IP Right Grant
- 2012-06-15 KR KR1020137034615A patent/KR102019520B1/en active IP Right Grant
- 2012-06-15 EA EA201490032A patent/EA024937B1/en not_active IP Right Cessation
- 2012-06-15 MX MX2013014894A patent/MX338017B/en active IP Right Grant
- 2012-06-15 AU AU2012268987A patent/AU2012268987B2/en active Active
- 2012-06-15 JP JP2014515216A patent/JP5981538B2/en active Active
- 2012-06-15 SI SI201230600A patent/SI2720710T1/en unknown
- 2012-06-15 DK DK12728509.6T patent/DK2720710T3/en active
- 2012-06-15 MY MYPI2013702439A patent/MY170630A/en unknown
- 2012-06-15 PT PT127285096T patent/PT2720710E/en unknown
- 2012-06-15 PL PL12728509.6T patent/PL2720710T3/en unknown
- 2012-06-15 PE PE2013002832A patent/PE20141265A1/en not_active Application Discontinuation
- 2012-06-15 EP EP16161448.2A patent/EP3056211A1/en not_active Withdrawn
- 2012-06-15 ES ES12728509.6T patent/ES2575732T3/en active Active
- 2012-06-15 CN CN201280029683.2A patent/CN103619347A/en active Pending
- 2012-06-15 EP EP12728509.6A patent/EP2720710B1/en active Active
- 2012-06-15 WO PCT/EP2012/061495 patent/WO2012172072A1/en active Application Filing
- 2012-06-15 CA CA2836667A patent/CA2836667C/en active Active
- 2012-06-15 HU HUE12728509A patent/HUE028355T2/en unknown
- 2012-06-15 AR ARP120102140A patent/AR086956A1/en not_active Application Discontinuation
- 2012-06-15 US US14/126,937 patent/US9326944B2/en active Active
- 2012-06-15 RS RS20160453A patent/RS54875B1/en unknown
- 2012-06-15 CN CN201710984784.XA patent/CN107715104A/en active Pending
- 2012-06-15 SG SG2013085162A patent/SG195021A1/en unknown
- 2012-06-15 UA UAA201314452A patent/UA113174C2/en unknown
-
2013
- 2013-11-20 ZA ZA2013/08698A patent/ZA201308698B/en unknown
- 2013-12-17 CL CL2013003618A patent/CL2013003618A1/en unknown
- 2013-12-17 IL IL229977A patent/IL229977A/en active IP Right Grant
-
2014
- 2014-01-15 CO CO14006968A patent/CO6940377A2/en unknown
- 2014-01-17 EC EC2014013157A patent/ECSP14013157A/en unknown
-
2016
- 2016-04-26 US US15/138,240 patent/US20160228374A1/en not_active Abandoned
- 2016-05-27 HR HRP20160566TT patent/HRP20160566T1/en unknown
- 2016-06-22 CY CY20161100564T patent/CY1117933T1/en unknown
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